Symbiotica Specialty Ingredients - Research Development ... · symbiotica speciality ingredients...

Symbiotica Speciality Ingredients Sdn. Bhd.

Malaysia


Malaysia

Established since 2001

Manufacturing Facility in Kulim, Kedah

First Regionally Owned Manufacturer of APIs in Malaysia and ASEAN

Text


Malaysia


Malaysia

Research Development & Manufacture of Active Pharmaceutical Ingredients

Core Activity


Malaysia

PIC/S - ICH Q7A GMP CERTIFICATION - NPRA, MALAYSIA

US FDA - INSPECTED AND ACCEPTED FACILITY

COFEPRIS, MEXICO - GMP CERTIFICATION

EDQM CERTIFICATE OF SUITABILITY - 8 PRODUCTS, 2 UNDER EVALUATION

US DMF - 8 FILED, 10 MORE BEING FILED

REPHINE, UK PHARMASSES GMP

MNC - APPROVED SUPPLIERS TO GSK, SANOFI, TAKEDA, MYLAN, STADA, TEVA

IS0 9001:2008 CERTIFICATION - BUREAU VERITAS CERTIFICATION

Accreditation, Certification and Filings


Malaysia


Malaysia

The Beginnings

2000 - 01 :- Period of Establishment. - Development. - Commercialisation ( 1 kg Batches ).

2002 - 03 : - Pioneer status. - Scale up ( 5 kgs Batches ).

2004 - 06 :- Expansion & upgrading works ( Grade D Cleanroom of class 100 K ). - GMP certification - ICHQ7A-PIC/S and WHO. - ISO Certification. - First CEP application.

2007 - 09 :- Export Excellence Award ( MITI - MATRADE ). - Enterprise 50 awards - 6th Position ( SME corp - Delloite Malaysia). - First CEP awarded from EDQM - for Dexamethasone Sodium Phosphate. - More CEP applications - for additional produtcs began.

2010 - 12 :

- First Major expansion on existing site by addition of adjacent buildings, raising of work space height - Scale up ( 20 kgs batches ). - A separate facility for non-steroidal API was set up on the same site. - Three major MNC supply audits and commercial contracts. - US market developmental efforts - filing of US DMFs. - Awarding of more CEPs.

2013 - 17 :

- First US FDA inspection took place by mid 2014 which was successful & entry into the USA market - Cofepris GMP certified. - New site of 15.14 acres was acquired at the nearby Kulim High Tech Park & additional industrial buildings

in Taman Industri Waja for the future growth strategy. - Additional CEP filings and DMF compilations made.


Malaysia

Symbiotica Today

Turnover of USD 17 Million approx.

Manufacturing nearly 40 APIs in batch sizes of 1 kg - 100 kgs.

85 % of revenue contributed by exports, one of the largest exporters from the Malaysian Pharmaceutical Industry.

Market presence in over 50 countries worldwide : Asia-pacific, Middle east, Russia, Balkans, Africa, Maghreb, Western EU, Eastern EU, North America, Central America, Latin America etc.

GMP certified as per the ICH Q7 A guidelines by NPRA, Malaysia, a PIC/S member country, qualified to provide written confirmation as per new EC directive.

Successfully inspected and accepted by the US FDA in July 2014.

Cofepris GMP certified.

Audited regularly by MNCs, EU clients, Independent EU audit agencies & other overseas clients.

Hold 8 CEPs & filed 8 US DMFs.

Winner of 2 awards – EXPORT EXCELLENCE from MITI & ENTERPRISE 50 from SME Corp.

Regular participant in International Pharma fairs.

Team of 80 people.


Malaysia

Believe in Symbiosis, Function with Specialization & Synergy,

Deliver Ingredients with Quality, Serve with Excellence,

Live with passion ! Make the world

Happy, Healthy & lively, as a Life Sciences Company.

Philosophy


Malaysia


Malaysia

QualityCore Competence

Trust

ServiceFlexibilityReliability

Competitiveness


MalaysiaQuality Department

Quality Assurance

Quality Control

Validation Regulatory Affairs


Malaysia

Pharmaceutical Inspection Cooperation Scheme ( PIC/S ) / ICH Q7A

Certified by

National Pharmaceutical Regulatory AgencyMalaysia

ISO 9001: 2008 Certified by

Bureau Veritas Quality International

Quality Management System

QMS managed and implemented through a 5 Step Plan

Internal AuditCertification

AuditClient Audits/ Vendor Audits

Local Regulatory Audits

International Regulatory

Audit


MalaysiaQuality Assurance

Responsible for Quality Management system and batch release

Ensures Compliance towards ICH Q7A GMP & ISO 9001:2008

Conducts Training & retraining to ensure that personnel follow SoPs

Effects Surveillance audits to enforce QMS & GMP

Carries out Annual Internal Audits & Management Review

Documentation preparation, implementation, review and control.

Designs & implements procedures related to validation involving process, cleaning procedures, equipment qualification, utility qualification.

Regulatory document management in terms of preparation, submission, registration, review of Drug Master Files as well as responding to regulatory queries from regulatory authorities and customers.

Approval, filing and review of change controls, deviations, CAPAs, etc.

Management of Annual Product Review, Customer Complaints & Investigation when necessary.

Issuance & Review of Batch Manufacturing Records.

Preparation and maintenance of Master Protocol such as SoP list & Validation Protocol

Management of Vendor Qualification.


Malaysia

RA

Filing of Drug Master files

Common Technical Documents Technical Packs

Registration with authorities,

Answering of queries of

authorities & customers

CEP/COSRAUS DMFs

BETAMETHASONE VALERATE

BETAMETHASONE DIPROPIONATE

CLOBETASOL PROPIONATE

DEXAMETHASONE SODIUM PHOSPHATE

HALOBETASOL PROPIONATE

HYDROCORTISONE VALERATE

MOMETASONE FUROATE

EXEMESTANE

BETAMETHASONE VALERATE

BETAMETHASONE DIPROPIONATE

BETAMETHASONE SODIUM PHOSPHATE

CLOBETASOL PROPIONATE

DEXAMETHASONE SODIUM PHOSPHATE

MOMETASONE FUROATE

PREDNISOLONE ACETATE

TIBOLONE

APPLIED : EXEMESTANE TESTOSTERONE PROPIONATE

RA

Regulatory Affairs


MalaysiaManufacturing Site - Current

Steroidal Block

10 Mts/Annum

Non-Steroidal Block

20 Mts/Annum

Multiproduct Site

Kulim, Kedah, Malaysia


Malaysia


Malaysia

Facility is spread over 27,000 sqft (2,500 m2 ) land area with 2 separate manufacturing blocks for Steroidal and Non-Steroidal APIs. Centralized warehouse is located inside a separate building.

Raw materials are subjected to quarantine, sampling & QC release prior to dispensing in separate and dedicated Down-Flow Booths prior to transfer for production.

Production involves various chemical synthetic steps involving reaction, distillation, extraction, separation etc., which are carried out in the Crude Chemical area. This area is equipped with Reactions Vessels made of Stainless Steel, Mild-Steel-Glass-Lined, Full-Glass, etc. Condensers, Centrifuges, Neutsche Filters, Sparkler Filter, Tray Dryers, etc.

Final Powder Processing is carried out in a ISO Class 8 Clean-Room involving Drying, Milling, Micronization, Blending, Packing etc. Equipments used in this area are Tray Dryers, Vacuum Tray Dryers, Rotary Cone Vacuum Dryers, Blenders, Mills and Micronizers. Packing is carried out only after final QA batch release. In-Process Quality Control ensures adherence to standard procedures for consistent Quality under GMP compliance

Plant utilities involve Huber Temperature Control Systems, Chillers, Nitrogen Generator, Vacuum Pumps, DI water system, Scrubber, Evaporative Ventilation Systems, Exhausts, Air-Handling Units etc.

Manufacturing activity


Malaysia

519 518 517

Centralized Warehouse

Steroidal Chemical Area

Steroidal Powder Processing

Non-Steroidal Chemical Area

Non-Steroidal Powder

Processing Area

Common Zone

QC-Int QC-W

Facility Layout


Malaysia

Manufacturing Sites

Address 518, Jalan Waja 4, Taman Industri Waja, 09000, Kulim, Kedah

Size 27,000 sft

Certifications NPRA - ICH Q7A : PIC/S GMP certification ( Last inspection - Sep’15 )

US FDA - successfully inspected and accepted ( Last inspection - July’14 )

Site I : Current

Address Lot 4, Industrial Zone Phase 2, Kulim Hi-tech Park, 09000, Kulim, Kedah

Size 15.14 acres ( 659,498.4 sft )

Certifications -

-

Site II : New - Green Field


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New Site

Current Site

Location of the the Sites


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Symbiotica - II

Kulim Hitech industrial estate Targeted date of completion : End 2018 15.14 Acres / 612700 sqm / 659499 sqft


Malaysia

Sterile Steroidal API - Crystallized / Lyophilized

Non-steroidal API Block

Additional Steroidal & Hormonal API Blocks

Steroid Intermediate Blocks

Fermentation Block

Phytochemical R&D and Industrial facility

Proposed Activities at the New Green Field Site


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=

Symbiosis

Customization

Reliability

Trustability

Associate with a spirit of Symbiosis towards mutually beneficial co-existence in all spheres - Internally & Externally

Customized solutions in terms of tailoring quality, packaging, sterilization, analysis etc to suit customer needs. Impurity profile, Particle size distribution etc are customizable.

Very high level of reliability achieved through Prompt responsiveness, Maintenance of ample inventory levels, Secure QMS, Timely deliveries etc.

Responsible approach towards servicing of client’s regulatory needs, effective & empathetic handling of customer feedbacks, successfully undergoing audits with an open & transparent attitude, etc have contributed towards a very strong factor of trust amongst clientele.

Our Values


Malaysia

An experiment that Metamorphosed to a rich & great experience.

Challenges of operating an API manufacturing company in Malaysia have been successfully met.

Global reputation as a major player in the steroidal API field and one of the few companies that produces Pinaverium Bromide ( Non-steroidal API ).

First Asian company to obtain CEP for Dexamethasone Sodium Phosphate – first one to get it after Sanofi and Pfizer.

First Asian company to obtain CEP for Tibolone and the second in the world after an Italian mfr.

Approved supplier to major MNCs – GSK, Sanofi Aventis, Takeda, Mylan, Stada, Teva

Epilogue


MalaysiaBECLOMETHASONE DIPROPIONATE * BETAMETAMETHASONE ACETATE BETAMETHASONE DIPROPIONATE *+ BETAMETHASONE SODIUM PHOSPHATE * BETAMETHASONE VALERATE *+ BUDESONIDE CLOBETASOL PROPIONATE *+ CLOBETASONE BUTYRATE CLOSTEBOL ACETATE DEFLAZACORT DEXAMETHASONE SODIUM PHOSPHATE *+ DROSPIRENONE EXEMESTANE *+ HALOBETASOL PROPIONATE + HYDROCORTISONE BUTYRATE HYDROCORTISONE HEMI SUCCINATE * HYDROCORTISONE VALERATE + METHYL PREDNISOLONE ACEPONATE METHYL PREDNISOLONE HEMI SUCCINATE * MOMETASONE FUROATE *+ PREDNICARBATE * PREDNISOLONE ACETATE * PREDNISOLONE HEMI SUCCINATE PREDNISOLONE PIVALATE PREDNISOLONE SOD. METASULFOBENZOATE PREDNISOLONE SODIUM PHOSPHATE * TESTOSTERONE PROPIONATE TIBOLONE *

STEROIDS

TextProducts with REGULATORY Package

* CEP + US DMF * CEP under application Others – CTD available

Customizations :

MicronizationTerminal Sterilization :Gamma radiation @ 10-15 KGY

Dose


Malaysia

DIFLORASONE DIACETATE DESONIDE DEXAMETHASONE DIMETHYL BUTYRATE DEXAMETHASONE DIPROPIONATE DEXAMETHASONE ISONICOTINATE DEXAMETHASONE PALMITATE DEXAMETHASONE PHENYL PROPIONATE DEXAMETHASONE PIVALATE DEXAMETHASONE SOD. METASULFOBENZOATE DEXAMETHASONE VALERATE FLUMETHASONE PIVALATE FLUOCINONIDE HYDROCORTISONE ACEPONATE HYDROCORTISONE BUTYRATE PROPIONATE METHYL PREDNISOLONE ACETATE PREDNISOLONE VALERATE ACETATE TRIAMCINOLONE ACETONIDE TRIAMCINOLONE DIACETATE TRIAMCINOLONE HEXAACETONIDE TRILOSTANE

STEROIDS

Products which can be upgraded to

REGULATORY Package against

committed projects with potential

partners

Customizations :

MicronizationTerminal Sterilization :Gamma radiation @ 10-15 KGY

Dose


Malaysia

PINAVERIUM BROMIDE

NON-STEROIDS

Supported with REGULATORY Package in terms of a CTD format DMF ( ASMF, EDMF ). Audited by

COFEPRIS, Mexico.


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P R O D U C T U S D M F N O . BETAMETHASONE DIPROPIONATE 24486

BETAMETHASONE VALERATE 27210

CLOBETASOL PROPIONATE 24015

DEXAMETHASONE SODIUM PHOSPHATE 24215

EXEMESTANE 25275

HALOBETASOL PROPIONATE 30906

HYDROCORTISONE VALERATE 31423

MOMETASONE FUROATE 26153

US FDA - Products with DMF Numbers


MalaysiaP R O D U C T N D C N O .

Beclomethasone Dipropionate 52128-128-01Betamethasone Acetate 52128-131-01Betamethasone valerate 52128-125-01Betamethsone Dipropionate 52128-123-01Betamethsone Sodium phosphate 52128-124-01Clobetasol Propionate 52128-121-01Deflazacort 52128-135-01Dexamethasone Sodium phosphate 52128-122-01Exemestane 52128-134-01Halobetasol propionate 52128-138-01Hydrocortisone butryate 52128-130-01Hydrocortisone valerate 52128-136-01Methylprednisolone Aceponate 52128-139-01MethylPrednisolone Acetate 52128-148-01Mometasone Furoate 52128-126-01Pinaverium bromide 52128-137-01Prednicarbate 52128-129-01Prednisolone Hemi Succinate 52128-149-01Prednisolone sodium phosphate 52128-127-01Testosterone Propionate 52128-142-01Tibolone 52128-146-01Triamcinolone Acetonide 52128-143-01Triamcinolone diacetete 52128-145-01Triamcinolone Hexacetonide 52128-144-01

US FDA - NDC Listed products


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P R O D U C T C E P / C O S N O .

BETAMETHASONE DIPROPIONATE R0-CEP 2011-005-Rev 00

BETAMETHASONE SODIUM PHOSPHATE R0-CEP-2013-326-Rev 00

BETAMETHASONE VALERATE R1-CEP 2008-215-Rev 00

CLOBETASOL PROPIONATE R1-CEP 2009-221-Rev 00

DEXAMETHASONE SODIUM PHOSPHATE R1-CEP 2006-184-Rev 00

MOMETASONE FUROATE R1-CEP 2009-313-Rev 00

PREDNISOLONE ACETATE R0-CEP-2014-138-REV 00

TIBOLONE R1-CEP 2010-294-Rev 00

EDQM - Product/CEP Numbers


Malaysia

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